FDA Inspection
Jiangsu Guangda Medical Material Group Co., Ltd.Jiangsu Guangda Medical Material Group Co., Ltd. – FDA Inspection, Aug 31, 2023
Record Details
This FDA Inspection record concerns Jiangsu Guangda Medical Material Group Co., Ltd., with an inspection on August 31, 2023, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- August 31, 2023
- Product Type
- Devices
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ID · adfdb37e-b398-4cb9-8472-e9733e4e2c92
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1217706
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
12- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
Showing 10 of 12 citations.
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Other FDA inspections of Jiangsu Guangda Medical Material Group Co., Ltd.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| December 5, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 10, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 19, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Jiangsu Guangda Medical Material Group Co., Ltd.
- FDA Inspection 1081397 - 2018-12-05
- FDA Inspection 926501 - 2015-04-10
- FDA Inspection 802595 - 2012-09-19
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